Digital Therapeutic for Depression After Traumatic Brain Injury

Overseen By Olivia Shaw

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Antidepressants

Disqualifiers: Psychotic, Bipolar, Suicide, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

113 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a mobile app designed to help military service members and veterans with mild traumatic brain injury reduce their depression. The app helps users change negative thoughts and behaviors to improve their mood. This type of therapy has been shown to be effective for various mental health issues, including depression, and can be delivered through different methods such as mobile apps.

Research Team

David Brody, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

This trial is for current and former US military personnel aged 18-65 who have had a mild traumatic brain injury (mTBI) and are experiencing mild to moderate depression. Participants must own or have access to a smartphone with internet, be able to consent, and maintain regular mental health care. Those on new depression treatments or with recent medication changes, psychotic/bipolar symptoms, safety concerns, or active suicidal/homicidal plans cannot join.

Inclusion Criteria

I have been diagnosed with a mild traumatic brain injury according to VA and DoD standards.

You have a score of 5 or higher on the PHQ-9 test, which shows that you have mild or more severe signs of depression.

Be able to provide informed consent

Exclusion Criteria

I started treatment for depression in the last 3 months.

I have changed my antidepressant type or dose in the last 12 weeks.

I am experiencing symptoms of psychosis or bipolar disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cognitive-behavioral therapy digital therapeutic or an educational digital therapeutic

12 weeks

Remote participation

Follow-up

Participants are monitored for changes in depression severity and other outcomes

4 weeks

Treatment Details

Interventions

• CNRM DTx
• Psychoeducation Comparison

Trial Overview The study is testing a mobile app that uses cognitive-behavioral therapy (CBT) designed for those with mTBI-related depression against an educational app. The goal is to see if the CBT-based digital therapeutic can help reduce depressive symptoms more effectively than just receiving psychoeducational content.

Participant Groups

Group I: CBT DTx Experimental Treatment 1 Intervention

Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention.

Group II: Psychoeducations DTx Active Control 1 Intervention

Participants randomized to the comparison group will access an unstructured educational DTx.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+